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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

LD50> 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
fixed dose procedure
Limit test:
other: Tif: RAIf (SPF)
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 161-201 g
- Age: 7-8 weeks
- Fasting period before study: 22 h
- Housing: single animale per cage
- Diet: commercial rat food, NAFAG No. 890, NAFAG AG, Gossau CH ad libitum
- Water: tap water ad libitum

- Temperature (°C): 22 ± 3
- Humidity: 55 ± 15 %
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
- approx. 15 air changes/h

Route of administration:
oral: gavage
Single dose: 2000 and 5000 mg/kg of the compound bw.
Volume: 10 ml/kg for lower dose and 20 ml/kg for higher dose
No. of animals per sex per dose:
5 for each sex
Total animals number : 20
Control animals:
not specified
Not applicable.
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
All the animals of both sexes in the 5000 mg/kg groups died after 1 day of the post-exsposure period.
Clinical signs:
Dyspnea, slight to moderate ruffled fur and abnormal body positions were seen, being common symptoms in acute tests.
Additionally diarrhea was detected in the animals of the 2000 mg/kg dose group up to day 2 after the administration.
Sedation and diarrhea was observed in the animals of the 5000 mg/kg bw dose group.
Body weight:
Determined at day: 1, 7 and 14 and at each death.
Gross pathology:
No change in any organs and tissues.
Interpretation of results:
other: not classified
Classification criteria according to the CLP Regulation 1272/2008 and its amendments
LD50 > 2000 mg/kg bw.
Executive summary:

The results show no toxicity with a LD 50 value > 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Acute oral toxicity

According to the CLP Regulation 1272/2008/EC, section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 values are > 2000 mg/kg/body weight.

The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.